Can a Red Light Helmet with or without Hyperbaric Oxygen Therapy improve cognition in adults with mild and moderate cognitive impairment? - Trial ANZCTR12623000845639
Access comprehensive clinical trial information for ANZCTR12623000845639 through Pure Global AI's free database. This Not Applicable trial is sponsored by Dr Karin Ried and is currently Not yet recruiting. The study focuses on Mild Cognitive Impairment.
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Study Focus
Sponsor & Location
Dr Karin Ried
National Institute of Integrative Medicine
Timeline & Enrollment
Not Applicable
Aug 31, 2023
Nov 30, 2023
Primary Outcome
Structural MRI assessing composite of change in hippocampal volume, grey cortical matter volume, and cortical thickness.;; Functional connectivity assessed by resting state functional MRI.;; Composite cognitive executive functioning assessed by four validated cognitive exams: Mini Mental State Examination (MMSE) Score Symbol Digits Modalities Test (SDMT) Score Hopkins Verbal Learning Test-Revised (HVLT-r) Score Montreal Cognitive Assessment (MoCA) Score
Summary
Cognitive ability, including memory and problem solving, declines with normal aging. For some people, this decline is more rapid, resulting in a condition known as mild cognitive impairment (MCI). MCI is a precursor for neurological conditions including dementia and Alzheimer’s disease. Despite considerable biotechnology and pharmaceutical investment, current pharmacological treatments for these conditions only temporarily alleviate symptoms with some 50% of people diagnosed showing no benefit with treatment. A growing body of research suggests alternative therapies such as photobiomodulation (PBM) and hyperbaric oxygen therapy (HBOT) may offer benefits to both the symptoms and progression of neurodegenerative diseases. This research will assess whether PBM, also called red light therapy, is an effective treatment for mild to moderate cognitive impairment and whether this effect is heightened by the combined treatment of HBOT. Treatment involves PBM therapy either alone or with HBOT for 8 or 16 weeks depending on treatment arm. Trial participants will undergo MRIs, cognitive tests and a series of blood tests at various time points over a 6-month period to assess immediate and long-term effects of PBM and HBOT on brain structure, function, and cognition. This study is exploratory and will provide important insights for future studies.
ICD-10 Classifications
Data Source
Australian New Zealand Clinical Trials Registry
ANZCTR12623000845639
Device Trial